Urinary tract infection (UTI) is the second most common type of infection in the US, accounting for 10.5 million office visits per year and 50 percent of all Medicare hospital admissions. UTI is among the most common cause of bacterial infections in long-term care facility residents.
Effective treatment of a UTI is reliant upon the accurate identification of the pathogens and the correct choice of antibiotics. Although culture-based clinical laboratory testing methods remain the gold standard for diagnosing UTI in both research and clinical laboratories, the clinical utility of such methods continues to be called into question.
This white paper provides insights on the status of clinical utility of rapid molecular testing for UTI, describes settings where molecular testing for UTI is of high value to improving outcomes, details experiences of successful early adopters of this technology.
Find these, and many more business-critical insights in this White Paper:
Learn why a large number of Gram-negative and especially Gram-positive organisms cannot grow in typical culture-based testing conditions, leading to false negatives and missed organisms in a polymicrobial UTI
See a comparison study of traditional urine culture testing to multiplex polymerase chain reaction (PCR) molecular testing, run in parallel, showing that the molecular method found six additional polymicrobial cases for every one found using urine cultures
How, in addition to higher detection rates, PCR can provide results in as little as 6 hours, and may facilitate more appropriate and efficacious treatment that improves clinical care and outcomes
Why insurers and other payers are now acknowledging molecular diagnostic testing, which includes deoxyribonucleic acid-(DNA) or ribonucleic acid-(RNA) based analysis, and much more
White Paper Table of Contents
Chapter 1: Problems and Limitations of Culture-Based Testing for UTI in Contrast to Molecular Testing
Chapter 2: Recent Clinical Trials Focused on UTI Diagnostics Using Rapid Molecular Testing
Chapter 3: Reimbursement Trends and Cost Versus Value in Molecular Testing for UTI
CONCLUSION
Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests.
Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications.
Find out how this innovative testing strategy could benefit your lab by downloading your FREE copy of “Molecular Testing for Urinary Tract Infection (UTI)” below.
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Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources
What better example do we have that clinical laboratory test data is critical to population health than the current COVID-19 pandemic? Medical laboratory scientists, bioinformatics developers, and government healthcare leaders are using lab test data to track the disease’s rate of infection, and through information system dashboards, they are mapping and managing the spread of SARS-CoV-2, the coronavirus that causes the COVID-19 illness.
One such example is the CV19 Lab Testing Dashboard developed by hc1 in Indianapolis, which “integrates SARS-CoV-2 testing data from more than 20,000 testing locations across the country, updating every four hours with information on the number of tests performed and the number of positive and negative results along with demographic information like the gender and age of patients being tested,” noted an article by 360Dx titled, “SARS-CoV-2 Pandemic a Test Case for Role of Lab Data in Population Health.”
“This pandemic is putting a spotlight on how important lab data is,” Brad Bostic, Founder, Chairman, and CEO of hc1, told the Indianapolis Business Journal (IBJ). His bioinformatics firm developed the CV19 dashboard, which draws on data created by a healthcare coalition of commercial and health system clinical laboratories that use the company’s High-Value Care Platform for lab testing.
The CV19 Lab Testing dashboard is free and provides a Local Risk Index that enables public health and government agencies, and healthcare providers, to monitor escalation of infection rate at the county level and predict the need for resources, noted an hc1 news release.
“We can offer insights [about the outbreak] seven to 14 days ahead of when emergency rooms and intensive care units get bogged down,” Bostic told the IBJ.
The hc1 dashboard provides healthcare providers with:
Test data collected from 20,000 locations covering 50 states and 90% of counties;
Information updates within minutes of SARS-CoV-2-PCR test results;
Test data that are quickly shared through an intuitive interface;
Geographic maps of test results that enable insight on COVID-19 infection rates at single county or Public Use Microdata Area level;
Number of tests per day, as well as positive and negative results; and
Displays of positivity rates and aggregated demographic information, such as gender and age.
Geisinger Health Uses Dashboard, Clinical Lab 2.0
The use of medical laboratory tests results in pursuit of population health also illustrates the value of the Clinical Lab 2.0 model, noted 360Dx.
According to 360Dx, Geisinger Health System, a leader in Clinical Lab 2.0, employs informatics tools for population-centric (as opposed to patient-focused) analysis of its SARS-CoV-2 testing. The Pennsylvania-based healthcare system uses lab testing dashboards to:
Review laboratory results in aggregate;
See positivity rates per county; and
Note amount of testing from sites.
“We needed to make sure that everyone could see the amount of testing that was being done, where that testing was coming from, and the results of that testing in a much [clearer] way. We began by setting up dashboards,” Jordan Olson, MD (above), a clinical pathologist and Geisinger’s Division Chief of Clinical Pathology, Informatics and Quality, told 360Dx. [Photo copyright: Cardinal Health/Whitehat Communications.)
Clinical Lab 2.0, a Project Santa Fe initiative, is a “business model leveraging longitudinal data to produce actionable clinical insight driving better outcomes for patients, providers, and stakeholders,” states the nonprofit organization’s website.
Sonora Quest Laboratories in Arizona also uses a dashboard to support its front-line healthcare workers to mitigate the spread of COVID-19, stated a news release.
“Most data flowing into public sector sites is eight to 14 days old, which in the case of COVID-19, is too told to react. Public health action requires the most immediate data possible, including test orders and results as soon as they appear,” said Meghan Shapiro Hunter, Vice President of Operations, Hospital Laboratories, Sonora Quest Laboratories, in the news release.
Other Informatics Technology Tracking COVID-19 Pandemic
Medial EarlySign develops AlgoMarkers that “perform algorithmic processing of lab results, clinical, and EHR data to provide condition-specific, post-analytical, personalized patient risk assessment scores to physicians, population health managers, and healthcare teams,” according to the medical informatics company’s website.
Headquartered in Israel, Medial worked with Maccabi Healthcare Services to develop an AlgoMarker that clinical laboratories, healthcare systems, and life sciences companies can use to spot trends in COVID-19 patients and make disease predictions based on risk, gender, co-morbidities, and medications, noted 360Dx.
Medial EarlySign also developed AlgoMarker algorithms to foresee influenza complications. According to a news release, the algorithms work by flagging people according to:
medical parameters,
demographics,
hospital admissions,
medications,
smoking history,
past diagnoses, and
chronic conditions.
Clinical Laboratory Data Enters the Spotlight
For some time now, medical laboratory data have been supporting positive outcomes and improving patient health from behind the curtain, so to speak. However, that appears to be changing fast as bioinformatics and medical informatics companies compile data in compelling dashboards aimed at helping public officials and healthcare providers manage the spread of COVID-19.
Pathologists, clinical laboratory leaders, and informatics specialists may want to explore use of dashboards to support their population health and COVID-19 testing efforts.
Current events have highlighted the critical role of the hospital laboratory as the primary source of diagnostic information. And with legislation such as PAMA (Protecting Access to Medicare Act) reducing reimbursement, hospital laboratories must determine the best direction in defining the role of the laboratory and its value to the hospital or health system.
Unfortunately, the laboratory’s critical role in determining diagnoses and treatments also makes it vulnerable to abuse. Studies estimate that from 10% to 25% of all hospital-performed laboratory tests in the inpatient setting are not indicated. Additionally, an increasingly complex, ever-expanding set of diagnostic test options necessitates heightened awareness in order to choose the right laboratory test at the right time.
Laboratory stewardship responds to these problems by establishing a true collaboration and partnership between the organization’s clinical leadership and the laboratory, to the benefit of both.
This white paper – the third in a three-part series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare – provides frontline perspective and commentary from experts and physicians on the application and value of decision support in the laboratory. It also includes early-adopter proof points from hospital laboratories that have successfully implemented third-party decision support to achieve their stewardship goals, including EHR interventions and ongoing monitoring of utilization.
This series aims to help clinical laboratory professionals like you understand the risks and requirements, as well as the clinical and financial benefits, of implementing a clinical decision support (CDS) system.
Find these, and many more business-critical insights in this White Paper:
Learn to define your lab’s specific stewardship goals and measure progress toward them using robust analytics tools, in order to compare provider behavior against evidence-based guidelines and equip your lab with the means to take control of test utilization
Understand clinically-grounded guidelines that you can apply in your lab to help address the now-prevalent problem of too much data and information for providers to consume, the result to the benefit of both patients and providers
Hear how one midwestern hospital identified that B-type natriuretic peptide (BNP) was frequently over-ordered on their wards, and the steps they took that led to a decline of 33%-43% in inappropriate BNP orders
Find out why looking at data at the facility level, then at the department level, then at the provider level is of greatest benefit to your lab, and much more
White Paper Table of Contents
Chapter 1: Taking Control of Test Utilization to Curb Clinical Laboratory Waste
Chapter 2: Reducing Variation in Laboratory Testing and Care Delivery
Chapter 3: Data from Lab Test Stewardship Using Third-Party Clinical Decision Support in the Hospital Laboratory
Case Study 1
Case Study 2
Case Study 3
CONCLUSION
A laboratory test stewardship program requires organizational attention, physician champions, meaningful data, and dedicated IT resources to enact changes—with decision support vital to driving a strategic stewardship initiative.
Moreover, as you, as a thought leader pursue the creation of a value-based laboratory, instead of a commoditized service, you will soon identify overutilization and inappropriate lab testing as areas to target for process improvement and cost savings, thus boosting your lab’s value and reinventing your role in your lab’s organization.
Learn what you need to know about these value-enhancing strategies by downloading your FREE copy of “Case Studies in Clinical Laboratory Test Stewardship” below.
Download the White Paper now by completing the form below.
Access to some white papers may require registration. In exchange for providing this free content, we may share your information with the companies whose content you choose to view. By accessing the white paper, you’re agreeing to our Terms of Service and Privacy Policy.
This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test
Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research allows it to be used in patient care. The goal of the researchers involved is to enable individuals to test for the SARS-CoV-2 coronavirus from home with the assistance of a smartphone app enhanced by artificial intelligence (AI).
Such an approach could bypass clinical laboratories by allowing potentially infected people to confirm their exposure to the coronavirus and then consult directly with healthcare providers for diagnosis and treatment.
The at-home test is being developed through a partnership between French pharmaceutical company Sanofi and San Jose, Calif.-based Luminostics, creator of a smartphone-based diagnostic platform that “can detect or measure bacteria, viruses, proteins, and hormones from swabs, saliva, urine, and blood,” according to the company’s website.
Users who wish to self-test collect a specimen from their nose via a swab and then insert that swab into a device attached to a smartphone. The device uses chemicals and nanoparticles to examine the collected sample. If the individual has the virus, the nanoparticles in the specimen glow in a way visible to smartphone cameras. The device generates data and AI in the smartphone app processes a report. The app informs the user of the results of this COVID-19 test, and it also enables the user to connect to a doctor directly through telehealth video conferencing to discuss a diagnosis.
“This partnering project could lead to another important milestone in Sanofi’s fight against COVID-19,” said Alan Main, Sanofi’s Executive Vice President, Consumer Healthcare, and Chair of the Global Self-Care Federation, in a press release. “The development of a self-testing solution with Luminostics could help provide clarity to individuals—in minutes—on whether or not they are infected.” (Photo copyright: Global Self-Care Federation.)
According to the press release, the diagnostic platform is composed of:
an iOS/Android app to instruct a user on how to run the test, capture and process data to display test results, and then to connect users with a telehealth service based on the results;
a reusable adapter compatible with most types of smartphones; and
consumables for specimen collection, preparation, and processing.
The COVID-19 test results are available within 30 minutes or less after collecting the sample, notes the Sanofi press release. Advantages cited for having a fast, over-the-counter (OTC) solution for COVID-19 testing include:
easy access and availability;
reduced contact with others, which lowers infection risk; and
timely decision-making for any necessary treatments.
The two companies plan to have their COVID-19 home-testing application available for the public before the end of the year, subject to government regulatory clearances. They intend to make their OTC solution available through consumer and retail outlets as well as ecommerce sites.
Can Sound Be Used to Diagnose COVID-19?
Another smartphone app under development records the sound of coughs to determine if an individual has contracted COVID-19. Researchers at the Swiss Federal Institute of Technology Lausanne (École Polytechnique Fédérale de Lausanne or EPFL) in Switzerland created the Cough-based COVID-19 Fast Screening Project (Coughvid), which utilizes a mobile application and AI to analyze the sound of a person’s cough to determine if it resembles that of a person infected with the SARS-CoV-2 coronavirus.
The inspiration for this project came from doctors who reported that their COVID-19 patients have a cough with a very distinctive sound that differs from other illnesses. The cough associated with COVID-19, according the EPFL website, is a dry cough that has a chirping intake of breath at the end.
“The World Health Organization (WHO) has reported that 67.7% of COVID-19 patients exhibit a ‘dry cough,’ meaning that no mucus is produced, unlike the typical ‘wet cough’ that occurs during a cold or allergies. Dry coughs can be distinguished from wet coughs by the sound they produce, which raises the question of whether the analysis of the cough sounds can give some insights about COVID-19. Such cough sounds analysis has proven successful in diagnosing respiratory conditions like pertussis [Whooping Cough], asthma, and pneumonia,” states the EPFL website.
“We have a lot of contact with medical doctors and some of them told us that they usually were able to distinguish, quite well, from the sound of the cough, if patients were probably infected,” Tomas Teijeiro Campo, PhD, Postdoc Researcher with EPFL and one of the Coughvid researchers, told Business Insider.
The Coughvid app is in its early developmental stages and the researchers behind the study are still collecting data to train their AI. To date, the scientists have gathered more than 15,000 cough samples of which 1,000 came from people who had been diagnosed with COVID-19. The app is intended to be used as a tool to help people decide whether to seek out a COVID-19 clinical laboratory test or medical treatment.
“For now, we have this nice hypothesis. There are other work groups working on more or less the same approach, so we think it has a point,” said Teijeiro Campo. “Soon we will be able to say more clearly if it’s something that’s right for the moment.”
With additional research, innovative technologies such as these could change how clinical laboratories interact with diagnosticians and patients during pandemics. And, if proven accurate and efficient, smartphone apps in the diagnosis process could become a standard, potentially altering the path of biological specimens flowing to medical laboratories.
Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus
In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and had the necessary resources, to develop their own coronavirus molecular diagnostic tests to help meet the nationwide demand for clinical laboratory testing. However, the response from the US Food and Drug Administration (FDA) was, in essence, “not so fast.”
In this second part of Dark Daily’s two-part e-briefing, we continue our coverage of the Washington Post (WP) investigation that detailed the regulatory hurdles which blocked private laboratories from deploying their own laboratory-developed tests (LDTs) for COVID-19. The report is based on previously unreported email messages and other documents reviewed by the WP, as well as the newspaper’s exclusive interviews with scientists and officials involved.
The CDC’s COVID-19 test kits began arriving at public health laboratories on February 8, just 18 days after the first case of the novel coronavirus was confirmed in the US. As the WP noted in an earlier analysis, titled, “What Went Wrong with Coronavirus Testing in the US,” the CDC’s decision to develop its own test was not surprising. “The CDC will develop [its] own test that is suited to an American healthcare context and the regulations that exist here,” explained Jeremy Konyndyk, Senior Policy Fellow at the Center for Global Development. “That’s how we normally would do things.”
But state and local public health laboratories quickly discovered that the CDC test kits were flawed due to problems with one of the reagents. While numerous academic, research, and commercial labs had the capability to produce their own COVID-19 PCR tests, FDA rules initially prevented them from doing so without a federal Emergency Use Authorization (EUA).
The bureaucratic hurdles arose due to Health and Human Services Secretary Alex Azar’s January 31 declaration that COVID-19 was a “health emergency” in the US. By doing so, HHS triggered a mandate that requires CLIA-certified labs at universities, research centers, and hospitals to seek an EUA from the FDA before deploying any laboratory-developed tests.
Scientists, Clinical Laboratories Frustrated by Bureaucratic Delays and Red Tape
To make matters worse, the EUA process was neither simple nor fast, which exasperated lab scientists and clinical laboratory administrators. “In their private communications, scientists at academic, hospital, and public health labs—one layer removed from federal agency operations—expressed dismay at the failure to move more quickly, and frustration at bureaucratic demands that delayed their attempts to develop alternatives to the CDC test,” wrote the WP investigators.
In a Feb. 27 email to other microbiologists, Marc Couturier, PhD, Medical Director at ARUP Laboratories, a national reference laboratory network located in Utah, voiced his irritation with the red tape that stymied private laboratory development of COVID-19 tests. He wrote, “We have the skills and resources as a community, but we are collectively paralyzed by a bloated bureaucratic/administrative process,” reported the WP.
Keith Jerome, MD, PhD (above), Head of the Virology Division at the Fred Hutchinson Cancer Research Center in Seattle, maintains federal regulations muted one of the nation’s greatest assets in the fight against COVID-19. “The great strength the US has always had, not just in virology, is that we’ve always had a wide variety of people and groups working on any given problem,” he told MIT Technology Review. “When we decided all coronavirus testing had to be done by a single entity, even one as outstanding as CDC, we basically gave away our greatest strength.” (Photo copyright: Jonathan Hamilton/NPR.)
‘FDA Should Not Treat Labs Like They Are Creating Commercial Products’
According to Kaiser Health News (KHN), Greninger was able to identify one of the nation’s first cases of community-acquired COVID-19 by taking “advantage of a regulatory loophole that allowed the lab to test samples obtained for research purposes from UW’s hospitals.”
But navigating the EUA process was a different story, Greninger told the WP. He spent more than 100 hours filling out forms and collecting information needed for the EUA application. After emailing the application to the FDA, Greninger received a reply containing eCopy Guidance telling him he needed to resubmit the information to the Document Control Center (DCC) at the Center for Devices and Radiological Health (CDRH), a federal agency Greninger knew nothing about. Another FDA rule required that the submission be copied to a hard disk and mailed to the DCC.
In an interview with ProPublica, Greninger stated that after he submitted his COVID-19 test—which copies the CDC protocol—an FDA reviewer told him he would need to prove the test would not show a positive result for someone infected with either a SARS or MERS coronavirus. The first SARS coronavirus disappeared in mid-2003 and the only two cases of MERS in the US were diagnosed in 2014. Greninger told ProPublica it took him two days to locate a clinical laboratory that could provide the materials he needed.
Greninger maintains the FDA should not treat all clinical laboratories as though they are making a commercial product. “I think it makes sense to have this regulation when you’re going to sell 100,000 widgets across the US. That’s not who we are,” he told ProPublica.
FDA Changes Course
Under pressure from clinical laboratory scientists and medical doctors, by the end of February the FDA had issued new policy that enabled CLIA-certified laboratories to immediately use their validated COVID-19 diagnostics while awaiting an EUA. “This policy change was an unprecedented action to expand access to testing,” said the FDA in a statement.
Since then, the FDA has continued to respond—albeit slowly—to scientists’ complaints about regulations that hampered the nation’s COVID-19 testing capacity.
Clinical laboratory leaders and pathologists involved in testing for the SARS-CoV-2 coronavirus should monitor the FDA’s actions and be aware of when and if certain temporary changes the agency implemented during the early days of the COVID-19 pandemic become permanent.
To read part one of our two-part coverage of the Washington Post’s investigation, click here.
Previously unreported email messages and documents paint vivid picture of public health laboratory officials’ dismay and frustration over testing delays
Between late January and early March, Clinical laboratory leaders watched with dismay as federal government missteps crippled the Centers for Disease Control and Prevention’s (CDC) rollout of its COVID-19 diagnostic testing in the early days of the pandemic. The resulting lack of testing capacity enabled the novel coronavirus’ spread across the United States.
This first part of Dark Daily’s two-part e-briefing covers how investigators at the Washington Post (WP) have produced a timeline describing the CDC initial failure to produce a reliable laboratory test for COVID-19 and the regulatory hurdles that blocked medical laboratories from developing their own tests for the virus. The WP’s report is based on previously unreleased email messages and other documents reviewed by the WP, as well as the newspaper’s exclusive interviews with medical laboratory scientists and officials involved.
A New York Times report on the federal government’s initial review of the testing kit failure pinned the blame on sloppy practices at CDC laboratories in Atlanta and a lack of expertise in commercial manufacturing. However, the WP reported that COVID-19 testing kits were delayed due to a “glaring scientific breakdown” at the central lab, created when the CDC facilities that assembled the kits “violated sound manufacturing practices” that resulted in cross contamination of testing compounds.
The US and other countries have criticized China for a lack of transparency about the virus’ emergence, which came to light on December 31, 2019, when China reported a cluster of pneumonia cases in Wuhan, according to a World Health Organization (WHO) timeline. A week later, Chinese authorities identified the pneumonia-like illness as being caused by a new novel coronavirus.
In the US, the first case of COVID-19 was found January 21 in a Washington State man who had traveled to Wuhan. But in the weeks that followed, the US government’s inability to establish a systematic testing policy became the catalyst for the virus’ ultimate spread to more than two million people, notes the CDC website.
ProPublica, which conducted its own investigation into the early stages of the government’s coronavirus response, blamed the failures on “chaos” at the CDC and “an antiquated public health system trying to adapt on the fly.”
The CDC’s first mistake may have been underestimating the danger COVID-19 posed to public health in this country. During a January 15 conference call, CDC scientists assured state and county public health officials that the agency was developing a COVID-19 diagnostic test which soon would be available, but which may not be needed “unless the scope gets much larger than we anticipate right now,” reported the WP.
A week later, an interview with CNBC, President Trump said, “We have it under control. It’s going to be just fine.”
CDC scientists designed their test in seven days, which, according to the WP investigators, is “a stunningly short period of time for a healthcare system built around the principles of medical quality and patient safety, not speed.” But when those initial CDC-made tests arrived at a New York City public health laboratory on February 8, lab technicians discovered the COVID-19 assays often indicated the presence of the coronavirus in samples that the lab’s scientists knew did not contain the virus.
When the scientists informed Lab Director Jennifer Rakeman, PhD, Assistant Commissioner, New York City Department of Health and Mental Hygiene, her response, according to the WP, was “Oh, s—. What are we going to do now?”
That night, Director Jill Taylor, PhD, Director of New York State’s Wadsworth Center public health reference laboratory, emailed state health officials, stating, “There is a technical problem in one of the reagents which invalidates the assay and will not allow us to perform the assay,” reported the WP. “I’m sorry not to have better news.”
Scott Becker (above), Executive Director of the Association of Public Health Laboratories (APHL), voiced his concerns about the CDC’s flawed COVID-19 test kits in an email to a CDC official, reported the WP. “The states and their governors are going to come unglued,” Becker wrote, adding, “If the CDC doesn’t get ahead of this, it will be a disaster.” (Photo copyright: Bill O’Leary/The Washington Post.)
‘The Silence from CDC is Deafening’
On February 10, Joanne Bartkus, PhD, then-Lab Director of the Minnesota Health of Department, wrote to APHL Executive Director Scott Becker: “The silence from CDC … is deafening. What is going on?” reported the WP.
By the end of February, the Associated Press (AP) reported that only 472 patients had been tested for COVID-19 nationwide. By comparison, South Korea, which identified its first case of COVID-19 on the same day as the US, was testing 1,000 people per day.
A WHO spokesperson told the WP that, “… no discussions occurred between WHO and CDC (or other US government agencies) about WHO providing COVID-19 tests to the US.” When the CDC’s original COVID-19 test kit failed, there may not have been a Plan B. This may explain why the opportunity to contain COVID-19 through surveillance testing was lost during the weeks it took to design a fix for the CDC test and loosen regulations so clinical laboratories could develop their own tests.
As medical laboratory scientists and clinical laboratory leaders know, the lack of early COVID-19 testing was a public health failure and painted a false picture of the virus’ spread. Nearly five months after the first case of the virus was confirmed in the US, testing capacity may only now be outpacing demand.
Click here to read part two of our coverage of the Washington Post’s investigation.
